Clinical trial • Phase II • Musculoskeletal|Other
Tafamidis (free acid) for Transthyretin amyloidosis
Phase II trial of Tafamidis (free acid) for Transthyretin amyloidosis.
Overview
- Trial Therapeutic Area
- Musculoskeletal|Other
- Trial Disease
- Transthyretin amyloidosis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 05-02-2026
- First CTIS Authorization Date
- 11-03-2026
Trial design
Free Acid Tafamidis 61 mg capsule versus Tafamidis 61 mg tablet (bioequivalence comparison); dosing specified as 61 mg under fed conditions, schedule not further specified in source.-controlled Phase II trial across 1 site in Belgium.
- Comparator
- Free Acid Tafamidis 61 mg capsule versus Tafamidis 61 mg tablet (bioequivalence comparison); dosing specified as 61 mg under fed conditions, schedule not further specified in source.
- Target Sample Size
- 24
Eligibility
Recruits 24 Vulnerable populations not selected; no special consent/assent handling indicated..
- Vulnerable Population
- Vulnerable populations not selected; no special consent/assent handling indicated.
Recruitment
- Planned Sample Size
- 24
- Recruitment Window Months
- 2
- Consent Approach
- Informed consent approach not detailed in source; subjects are healthy adult volunteers and vulnerable population not selected; no information on assent, age-specific documents, or available languages.
Methods
- Site-based recruitment via Pfizer Clinical Research Unit (contact email PfizerVolRecruitment@pfizer.com, phone +3225567003) targeting healthy volunteers in Belgium.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 24
Belgium
- Earliest CTIS Part Ii Submission Date
- 27-02-2026
- Latest Decision Or Authorization Date
- 11-03-2026
- Processing Time Days
- 12
- Number Of Sites
- 1
- Number Of Participants
- 24
Sites
- Site Name
- Pfizer Clinical Research Unit
- Contact Person Name
- Constantino Kantaridis
- Contact Person Email
- PfizerVolRecruitment@pfizer.com
- Number Of Participants
- 24
Sponsor
Primary sponsor
- Full Name
- Pfizer Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Free Acid Tafamidis 61 mg Capsule
- Active Substance
- Tafamidis (free acid)
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Starting Dose
- 61 mg
- Dose Levels
- 61 mg
- Maximum Dose
- 61 mg
- Investigational Product Name
- Tafamidis 61 mg Tablet
- Active Substance
- Tafamidis
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Starting Dose
- 61 mg
- Dose Levels
- 61 mg
- Maximum Dose
- 61 mg
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